If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Protonix Side Effects Reported to FDA

Protonix Side Effect Report#9997724 Dizziness

This is a report of a 43-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Protonix (dosage: 40 Mg, Unk, start time: 2013), combined with:

Lisinopril (20 Mg, Daily)

and developed a serious reaction and side effect(s): Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in male patients, resulting in Dizziness side effect.

Protonix Side Effect Report#9993422 Diverticulum

This report suggests a potential ProtonixDiverticulum side effect(s) that can have serious consequences. A 88-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Protonix (dosage: Unk) starting NS. After starting Protonix the patient began experiencing various side effects, including: DiverticulumAdditional drugs used concurrently: NA.The patient was hospitalized. Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diverticulum, may still occur.

Protonix Side Effect Report#9935077 Oesophageal Perforation, Off Label Use

This Oesophageal Perforation problem was reported by a consumer or non-health professional from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease,cardiac failure congestive. On NS this consumer started treatment with Protonix (dosage: 40 Mg, 3x/day). The following drugs were being taken at the same time:

Lasix (40 Mg, 1x/day)

When using Protonix, the patient experienced the following unwanted symptoms/side effects: Oesophageal Perforation, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oesophageal Perforation, may become evident only after a product is in use by the general population.

Protonix Side Effect Report#9925368

This Death side effect was reported by a consumer or non-health professional from US. A 10-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Protonix (drug dosage: 40 Mg, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Protonix the consumer reported adverse symptoms, such as: These side effects may potentially be related to Protonix.

This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: dyspepsia, who was treated with Protonix (dosage: 2 Pills/day?taken By Mouth, start time:

Jan 22, 2014), combined with: NA. and developed a serious reaction and side effect(s): Diarrhoea, Dizziness, Fatigue, Dizziness, Hyperhidrosis, Asthenia, Nausea, Abdominal Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Diarrhoea side effect.

This report suggests a potential ProtonixBone Density Decreased side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease,abdominal pain upper and used Protonix (dosage: 40 Mg, Unk) starting 2012. After starting Protonix the patient began experiencing various side effects, including: Bone Density Decreased, Malaise, Productive Cough, Oropharyngeal Pain, Throat IrritationAdditional drugs used concurrently: NA. Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bone Density Decreased, may still occur.

Protonix Side Effect Report#9889678 Musculoskeletal Discomfort

This Musculoskeletal Discomfort problem was reported by a consumer or non-health professional from US. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Protonix (dosage: Unk). The following drugs were being taken at the same time:

Viagra (Unk)

When using Protonix, the patient experienced the following unwanted symptoms/side effects: Musculoskeletal DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Musculoskeletal Discomfort, may become evident only after a product is in use by the general population.

Protonix Side Effect Report#9881239 Neoplasm Malignant

This Neoplasm Malignant side effect was reported by a physician from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: gastrooesophageal reflux disease.The patient was prescribed Protonix (drug dosage: Unk, 1x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Protonix the consumer reported adverse symptoms, such as: Neoplasm MalignantThese side effects may potentially be related to Protonix.

Protonix Side Effect Report#9870245 Arthropathy, Off Label Use

This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: musculoskeletal discomfort,diabetes mellitus, who was treated with Protonix (dosage: 40 Mg, 1x/day, start time: NS), combined with:

Lantus (Unk, 2x/day)

and developed a serious reaction and side effect(s): Arthropathy, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Arthropathy side effect. The patient was hospitalized.

Protonix Side Effect Report#9868583 Feeling Jittery, Malaise

This report suggests a potential ProtonixFeeling Jittery side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Protonix (dosage: Unk) starting 201401. After starting Protonix the patient began experiencing various side effects, including: Feeling Jittery, MalaiseAdditional drugs used concurrently:

Toprol Xl (Unk)

Aspirin (Unk)

Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Feeling Jittery, may still occur.

This Vitamin B12 Deficiency problem was reported by a consumer or non-health professional from US. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease,dyspepsia. On NS this consumer started treatment with Protonix (dosage: NA). The following drugs were being taken at the same time: NA. When using Protonix, the patient experienced the following unwanted symptoms/side effects: Vitamin B12 Deficiency, Clostridium Difficile Infection, Predisposition To DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vitamin B12 Deficiency, may become evident only after a product is in use by the general population.

Protonix Side Effect Report#9855008 Feeling Jittery

This Feeling Jittery side effect was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Protonix (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Protonix the consumer reported adverse symptoms, such as: Feeling JitteryThese side effects may potentially be related to Protonix.

Protonix Side Effect Report#9852075 Pain

This is a report of a 83-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: gastrooesophageal reflux disease, who was treated with Protonix (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Pain side effect.

This report suggests a potential ProtonixNausea side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Protonix (dosage: Unk, 2x/day) starting 2013. After starting Protonix the patient began experiencing various side effects, including: Nausea, Malaise, Abdominal DiscomfortAdditional drugs used concurrently:

Celexa (Unk, 1x/day)

Mycophenolate Mofetil (500 Mg, 4x/day)

Tacrolimus (1 Mg, 3x/day)

Baby Aspirin (Unk, 1x/day)

Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.

Protonix Side Effect Report#9820818 Extravasation, Swelling

This Extravasation problem was reported by a pharmacist from US. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrointestinal haemorrhage. On

Jan 02, 2014 this consumer started treatment with Protonix (dosage: As Continuous Drip). The following drugs were being taken at the same time: NA. When using Protonix, the patient experienced the following unwanted symptoms/side effects: Extravasation, SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extravasation, may become evident only after a product is in use by the general population.

Protonix Side Effect Report#9804122 Hernia, Abdominal Discomfort

This Hernia side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: gastrooesophageal reflux disease.The patient was prescribed Protonix (drug dosage: 40 Mg, 2x/day), which was initiated on 201311. Concurrently used drugs: NA..After starting to take Protonix the consumer reported adverse symptoms, such as: Hernia, Abdominal DiscomfortThese side effects may potentially be related to Protonix.

This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: gastrooesophageal reflux disease,depression,migraine, who was treated with Protonix (dosage: 40 Mg, 1x/day, start time: NS), combined with:

Celexa (40 Mg, 1x/day)

Topamax (50 Mg, 2x/day)

Imitrex (Unk)

Acetaminophen W/oxycodone (7.5/325 Mg, As Needed)

Tramadol (50 Mg, As Needed)

Spiriva (Unk, 1x/day)

Albuterol (Unk)

Ventolin Hfa (Unk)

and developed a serious reaction and side effect(s): Pulmonary Embolism, Bronchitis, Malaise, Gastrooesophageal Reflux Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.

This report suggests a potential ProtonixPneumonia Viral side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Protonix (dosage: 40 Mg, 1x/day) starting NS. After starting Protonix the patient began experiencing various side effects, including: Pneumonia Viral, Pulmonary Oedema, Viral Sepsis, Diabetic Ulcer, Renal Failure Acute, Blood Glucose IncreasedAdditional drugs used concurrently: NA. Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia Viral, may still occur.

Protonix Side Effect Report#9779961 Pharyngeal Haemorrhage, Off Label Use

This Pharyngeal Haemorrhage problem was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anaemia,haemorrhage. On 2002 this consumer started treatment with Protonix (dosage: Unk (by Splitting 80 Mg Tablet In To Half), 2x/day). The following drugs were being taken at the same time: NA. When using Protonix, the patient experienced the following unwanted symptoms/side effects: Pharyngeal Haemorrhage, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pharyngeal Haemorrhage, may become evident only after a product is in use by the general population.

This Dizziness side effect was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Protonix (drug dosage: 30 Once Daily Taken By Mouth), which was initiated on

This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Protonix (dosage: Unk, start time: NS), combined with:

Zantac (Unk)

and developed a serious reaction and side effect(s): Diarrhoea, Abdominal Pain, Abdominal Distension, Gastrooesophageal Reflux Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Diarrhoea side effect.

This report suggests a potential ProtonixGastric Ulcer Haemorrhage side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Protonix (dosage: Unk) starting 2002. After starting Protonix the patient began experiencing various side effects, including: Gastric Ulcer Haemorrhage, ThrombosisAdditional drugs used concurrently:

Lyrica (75 Mg, 2x/day)

Altace (5 Mg, 2x/day)

Coreg (12.5 Mg, 2x/day)

Warfarin (2.5 Mg, Daily)

Carafate (Unk, 1x/day)

Levothyroxine (75 Ug, Daily)

Although Protonix demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastric Ulcer Haemorrhage, may still occur.

This Laboratory Test Abnormal problem was reported by a consumer or non-health professional from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastrooesophageal reflux disease. On NS this consumer started treatment with Protonix (dosage: 40 Mg, 1x/day). The following drugs were being taken at the same time:

Marinol (Unk)

Synthroid (Unk)

Baclofen (Unk)

Klonopin (Unk)

Robaxin (Unk)

Potassium (Unk)

Miralax (Unk, 3x/day)

Peri-colace (2 Df, 4x/day)

When using Protonix, the patient experienced the following unwanted symptoms/side effects: Laboratory Test Abnormal, Blood Test Abnormal, Gastrointestinal Stoma ComplicationThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Laboratory Test Abnormal, may become evident only after a product is in use by the general population.

This Dyspnoea side effect was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Protonix (drug dosage: 40 Mg, Daily), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Protonix the consumer reported adverse symptoms, such as: Dyspnoea, Arthritis, Lung DisorderThese side effects may potentially be related to Protonix.

Protonix Side Effect Report#9752413 Dizziness, Somnolence

This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: gastrooesophageal reflux disease,diabetes mellitus, who was treated with Protonix (dosage: 40 Mg, Daily, start time: 2004), combined with:

Glipizide (5 Mg, Unk)

Januvia (100 Mg, Unk)

and developed a serious reaction and side effect(s): Dizziness, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Protonix treatment in female patients, resulting in Dizziness side effect.

The appearance of Protonix on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Protonix Side Effects for Men?

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Protonix reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

Protonix I.V. (pantoprazole sodium)

Audience: Pharmacists, nurses and other healthcare professionals in institutional settings

Wyeth and FDA informed healthcare professionals of reports of glass vial breakage of Protonix I.V. during attempts to connect vials to spiked intravenous system adaptors. This may be a safety issue for pharmacists or nurses when preparing Protonix I.V. for Injection vials in combination with spiked intravenous system adaptors, both during manual assembly and while utilizing mechanical assistance.

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